December 10, 2019 – A DCRI Think Tank on Technology-Enabled Clinical Trials recently culminated in a paper in Circulation that summarized takeaways on electronic health records and mobile health technologies.

Although challenges remain in implementing technologies in clinical research, diverse stakeholders can work together to recognize the full potential of using electronic health records and mobile health technologies in clinical trials, according to a paper recently published after an October 2018 DCRI Think Tank.

DCRI Think Tanks are held to convene leaders across the health care industry to address the most critical gaps in clinical research. The October 2018 event, “Technology-Enabled Clinical Trials,” was chaired by Eric Peterson, MD, MPH, (pictured left), and Matthew Roe, MD, MHS, (pictured right), and brought together a diverse group of clinical trial stakeholders, including representatives from the U.S. FDA, the Centers for Medicare & Medicaid Services, the Veterans Affairs administration, academics, patient advocacy groups, medical insurers, pharmaceutical and device manufacturers, and mobile and electronic health record (EHR) companies.

The paper, which was published recently in Circulation, focuses on two main categories of technologies: EHRs and a mobile health technologies category that includes mobile and digital health apps, biosensors, and wearables. The opportunity in both spaces is great, the authors note; in 2018, venture capital funding invested over $8 billion in digital health technologies, exceeding investments made on all medical devices combined.

Electronic health records could improve trials in many ways, from planning and design to data collection to clinical events follow-up. As an example, the authors of the paper discussed the DCRI-led ADAPTABLE study, which recently used EHRs from the Patient-Centered Outcomes Research Network (PCORnet) to facilitate the enrollment of 15,000 patients. Challenges in the EHR space remain, such as inclusion of inaccurate or incomplete data, heterogeneous or inoperable EHR platforms, and privacy concerns. Solutions to these challenges require collaboration, such as PCORnet, which makes available continuously updated data at individual sites by linking them through creation of a research network. The paper’s authors also expect to see solutions come to the forefront as natural language processing and machine learning continue to evolve, helping to decode information stored in EHRs.

Mobile health technologies, including biosensors and wearables, also pose a significant opportunity in clinical trials, especially as mobile phone ownership becomes increasingly prevalent. However, adoption of new technologies, as well as people’s comfort level using them, varies based on age, education level, and other factors. “Such differences in access to mobile technology can potentially lead to systematic exclusion of important patient subgroups,” the authors note. “Studies need to consider these potential biases and provide alternatives that will allow for more representative patient recruitment and participation, such as providing frameworks that would permit internet participation, and traditional study processes, as well, within a single trial.”

“We made great strides at the DCRI Think Tank, and we are excited to share our progress via this publication,” Peterson said. “Obviously there is still more work to be done in these areas, which will require collaboration across disciplines and industries, but we are excited to continue conducting research as we work to leverage technology to its fullest potential.”

“We appreciate that so many experts in this area took the time to come together and discuss how to move forward with full implementation of technology in clinical trials to improve our research ecosystem,” Roe said. “Many of these technologies are quite novel, and face-to-face discussion is essential so we can share ideas and work toward solutions more efficiently.”

“Being involved in this think tank was a great opportunity to see firsthand how collaboration can help tackle obstacles in clinical research,” said DCRI fellow Guillaume Marquis-Gravel, MD, MSc, (pictured left), who served as the lead author for the paper. “I am confident about the future of tech-enabled trials because of the many interesting ideas from diverse stakeholders that led to this publication.”

Other DCRI contributors to the paper include Peterson, Roe, and Bray Patrick-Lake, MFS (formerly of the DCRI).

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